Development and optimization of a multiple-unit controlled release formulation of a freely water soluble drug for once-daily administration

International Journal of Pharmaceutics

Volumn 405, Issue 1-2, 2011, Pages 102-112

  Shamma, Rehab N ^a   Basalious, Emad B ^a   Shoukri, Raguia A ^a  

^a CAIRO UNIVERSITY   (Egypt)

Author keywords

Betahistine; Full factorial design; Ion exchange resin; M nire's disease; Microcapsules; Optimization

Indexed keywords

BETAHISTINE; EUDRAGIT; ION EXCHANGE RESIN; PLASTICIZER;

ARTICLE; CONTROLLED RELEASE FORMULATION; DRUG CAPSULE; DRUG COATING; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG RELEASE; DRUG SOLUBILITY; IN VITRO STUDY; PATIENT COMPLIANCE; PRIORITY JOURNAL;

ADMINISTRATION, ORAL; BETAHISTINE; CAPSULES; COMPUTER SIMULATION; DELAYED-ACTION PREPARATIONS; DRUG DELIVERY SYSTEMS; DRUG DESIGN; HUMANS; PARTICLE SIZE; RESINS, SYNTHETIC; SOLUBILITY; VASODILATOR AGENTS; WATER;

EID: 79151483250     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.12.003     Document Type: Article

References (36)

1. A. Akhgari, H. Afrasiabi Garekani, F. Sadeghi, and M. Azimaie Statistical optimization of indomethacin pellets coated with pH-dependent methacrylic polymers for possible colonic drug delivery Int. J. Pharm. 305 2005 22 30
2. V. Anand, R. Kandarapu, and S. Garg Ion-exchange resins: carrying drug delivery forward Drug Discov. Today 17 2001 905 914
3. E.B. Basalious, N. Shawky, and S.M. Badr-Eldin SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine I: development and optimization Int. J. Pharm. 391 2010 203 211
4. S.S. Borodokin Ion exchange resin and sustained release J. Swarbrick, J.C. Bolan, Encyclopedia of Pharmaceutical Technology vol. 8 1993 Marcel Dekker New York pp. 203-216
5. M. Cuna, J.L. Vila Jato, and D. Torres Controlled-release liquid suspensions based on ion-exchange particles entrapped within acrylic microcapsules Int. J. Pharm. 2 2000 151 158
6. S. Ensslin, K.P. Moll, H. Metz, and M. Otz Modulating pH-independent release from coated pellets: effect of coating composition on solubilization processes and drug release Eur. J. Pharm. Biopharm. 1 2009 111 118
7. Fabiani, F., 2003. Controlled release compositions of betahistine. Patent EP 502,642.
8. Fossati, F., 2005. Controlled release compositions of betahistine. Patent EP 1,158,963.
9. X. Guo, R. Chang, and M.A. Hussain Ion-exchange resins as drug delivery carriers J. Pharm. Sci. 11 2009 3886 3902
10. V.K. Gupta, M.W. Assmus, T.E. Beckert, and J.C. Price A novel pH- and time-based multi-unit potential colonic drug delivery system II. Optimization of multiple response variables Int. J. Pharm. 213 2001 93 102
11. R.S. Harland, A. Gazzaniga, M.E. Sangalli, and P. Colombo Drug/polymer matrix swelling and dissolution Pharm. Res. 5 1988 488 494
12. S. Haznedar, and B. Dortunc Preparation and in vitro evaluation of Eudragit microspheres containing acetazolamide Int. J. Pharm. 1 2004 131 140
13. T. Higuchi Rate of release of medicaments from ointment bases containing drugs in suspension J. Pharm. Sci. 50 1961 874 875
14. T. Higuchi Mechanism of sustained-action medication theoretical analysis of rate of release of solid drugs dispersed in solid matrices J. Pharm. Sci. 52 1963 1145 1149
15. Y.B. Huang, Y.H. Tsai, W.C. Yang, J.S. Chang, P.C. Wu, and K. Takayama Once-daily propranolol extended-release tablet dosage form: formulation design and in vitro/in vivo investigation Eur. J. Pharm. Biopharm. 58 2004 607 614
16. H. Ichikawa, K. Fujioka, M.C. Adeyeye, and Y. Fukumori Use of ion-exchange resins to prepare 100 microm-sized microcapsules with prolonged drug-release by the Wurster process Int. J. Pharm. 216 2001 67 76
17. W.J. Irwin, and K.A. Belaid Drug delivery by ion exchange Part I: ester prodrugs of propranolol Drug Dev. Ind. Pharm. 13 1987 2017 2031
18. Jean, S.C., Alain, C.D., 1981. New galenical form of adminstartion of betahistine and its derivative and the preparation thereof. US Patent 4,264,574.
19. M.R. Jenquin, R.E. Sarabia, S.M. Liebowitz, and J.W. McGinity Relationship of film properties to drug release from monolithic films containing adjuvants J. Pharm. Sci. 10 1992 983 989
20. S.H. Jeong, and K. Park Drug loading and release properties of ion-exchange resin complexes as a drug delivery matrix Int. J. Pharm. 361 2008 26 32
21. V.B. Junyaprasert, and G. Manwiwattanakul Release profile comparison and stability of diltiazem-resin microcapsules in sustained release suspensions Int. J. Pharm. 352 2008 81 91
22. C. Kim, M. Kim, and K.O. Oh Preparation and evaluation of sustained release microspheres of terbutaline sulfate Int. J. Pharm. 3 1994 213 219
23. A. Kramar, S. Turk, and F. Vrecer Statistical optimisation of diclofenac sustained release pellets coated with polymethacrylic films Int. J. Pharm. 256 2003 43 52
24. M. Marvola, P. Nykanen, S. Rautio, and N. Isonen Enteric polymers as binders and coating materials in multiple-unit site-specific drug delivery systems Eur. J. Pharm. Sci. 3 1999 259 267
25. J.W. Moore, and H.H. Flanner Mathematical comparison of dissolution profiles Pharm. Tech. 6 1996 64 74
26. S. Motycka, C.J. Newth, and J.G. Nairn Preparation and evaluation of microencapsulated and coated ion-exchange resin beads containing theophylline J. Pharm. Sci. 6 1985 643 646
27. T.U. Okarter, and K. Singla The effects of plasticizers on the release of metoprolol tartrate from granules coated with a polymethacrylate film Drug Dev. Ind. Pharm. 3 2000 323 329
28. N.A. Peppas Analysis of Fickian and non-Fickian drug release from polymers Pharm. Acta Helv. 60 1985 110
29. T. Pongjanyakul, S. Prakongpan, U. Rungsardthong, P. Chancham, and A. Priprem Characteristics and in vitro release of dextromethorphan resinates Powder Technol. 152 2005 100 106
30. G.S. Rekhi, R.V. Nellore, A.S. Hussain, and L.G. Tillman Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets J. Control. Rel. 3 1999 327 342
31. J. Singh, A.K. Philip, and K. Pathak Optimization studies on design and evaluation of orodispersible pediatric formulation of indomethacin AAPS PharmSciTech. 1 2008 60 66
32. A.B. Solanki, J.R. Parikh, and R.H. Parikh Formulation and optimization of piroxicam proniosomes by 3-factor, 3-level Box-Behnken design AAPS PharmSciTech. 8 2007 E86
33. S.C. Sweetmant MartinDale: The Complete Drug Reference 2009 Pharmaceutical Press
34. D. Torres, L. Boado, L. Blanco, and J.L. Vila-Jato Comparison between aqueous and non-aqueous solvent evaporation methods for microencapsulation of drug-resin complexes Int. J. Pharm. 173 1998 171 182
35. J.G. Wagner Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules J. Pharm. Sci. 58 1998 1253 1257
36. R. Zelko, A. Orban, K. Suvegh, and Z. Riedl Effect of plasticizer on the dynamic surface tension and the free volume of Eudragit systems Int. J. Pharm. 244 2002 81 86